Quality Research Of Low Density Polyethylene Eye Drops Bottle

Low density polyethylene eye drop bottles,as a drug package materials contacting with drug directly,is an integral part of the drug.It takes part in the whole process of pharmaceutical production,circulation,storage and use.Due to the difference of its composition formula,the choice of raw material and excipient,and the production process.Some components may be dissolved by the contacting drug,migrate to the drug,release poisonous and harmful substances.Or have interactions with drug,adsorb the active ingredients 、 reduce the effective component contents,consequently influence the curative effect of medicine.This study comes from evaluating test task carried out by China food and drug administration about low density polyethylene eye drop bottles,which was undertaken by Hubei Institute For Food and Drug Control.The main content of the research lnclude :The first: Standard test results and analysis of low density polyethylene eye drop bottles.In order to analyze comprehensively the quality of this kind of bottles,The research random inspected a total of 33 batch samples from all over the country,involving 15 drug package materials production and the other 15 usage enterprises.32 batch were tested by YBB00062002,one batch of samples was carried out by enterprise standard Q / 75701098-0-002-2011,the percent of pass is 100%,The quality overall is about good.Comparing with European and American countries standards,National standard for material identification of low density polyethylene eye drops bottle lack the antioxygen content determination,and also lack test items of material blocking performance.Therefore,the current standards cannot effectively guarantee the quality safety of low density polyethylene eye drop bottles.Second:The consistency investigation of low density polyethylene eye drop bottles aggregate and the identification of recycled material.Though the survey,It was find that low density polyethylene bottle eye drops is made of the original aggregate,or masterbatch and titanium dioxide joining injection molding.In present market,in order to reduce the production cost,a few companies modify formula without authorization,or use recycle materials to produce medicinal packaging materials,which influence the quality of the eye drop bottles seriously and have a security risk.This topic has established quality research methods of the low density polyethylene eye drop bottles,through the consistency investigation of low density polyethylene eye drop bottles aggregate and the identification of recycled material,The research,carring in two aspects,identify whether eye drop bottles change formula or make use of recycled materials effectively.DSC analysis was used to make consistency inspection of the eye drop bottles and aggregate.It was though determining melt-out curve of sample to compare melt-out curve of aggregate and eye drops bottle.The content of six kinds of antioxygen in aggregate and eye drops bottle were determined by HPLC.The results show that: camparing with eye drop bottles,there exist inconsistencies on types and content in aggregate,which prompt inconsistencies formulation process.Together with melting curve,can accuratly judge consistency between aggregate and eye drop bottles.It was through DSC method to identify recycle material.through testing multi-aggregate,it was found that with the increase timesr of recycling,the peak of multiaggregate stretch,there are even two melting peaks,Oxidation induction temperature reduced and time shortened.Rheological analysis found that,with the increases quality molecular weight,polydispersity index decreases,and viscosity became higher.According to the law of of material ‘s physical and chemical properties change,it can be further identified recycling materials.Third: Near infrared consistency model was set up to distinguish new materials and recycling materials.Collect and analysis the near infrared spectrum of low density polyethylene eye drop bottles samples,new materials and recycling materials.Develop near infrared consistency model which can quickly distinguish between new material and eye drops bottle made of recycled materials many times.Fourth: The research of low density polyethylene eye drops bottle blocking performance.Low density polyethylene eye drop bottles ‘s block performance,for some easy oxidation of volatile drugs,the study found that this type of material is not stable in pharmaceutical package.In Blocking performance investigation,Choose different packaging materials of pearl bright eye drops,musk deer bead eyes,two kinds of eye drops containing borneol.Which were placed under the condition of accelerated test after 3 months and simulate conditions which opened bottle placed.Determined the content of borneol though the gas chromatography method,meanwhile,weighing method is adopted to test the water vapor permeability.Accelerated test results show that Polyester bottle ‘s blocking performance is the best,polypropylene bottle was the second,polyethylene bottle was the worst.To light the blocking performance,Eye drop bottles’ s light transmittance have great relationship with material and formula.Select photosensitive drugs(ofloxacin eye drops),and determine the content of related substances,The results show that there are positive correlation between relevant material ‘s content and eye drop bottles’ s light transmittance,which can provide the basis for enterprises to choose reasonable eye drop bottles.